Registration Dossier
Registration Dossier
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EC number: 267-007-0 | CAS number: 67762-26-9 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid methyl ester and SDA Reporting Number: 04-010-00.
Carcinogenicity
Administrative data
Description of key information
No relevance of carcinogenic effect/potential
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Remarks:
- read across on structural analogue
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is old, not GLP, but well described and scientifically valid
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.32 (Carcinogenicity Test)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- Strain A
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female inbred ST/a mice, originating from the Fibiger Laboratory and bred in our laboratory, were housed in macrolone cages and fed a pellet stok diet (Rostock mixture, Copenhagen) with water ad libitum. Preliminary experiments using hair colouring and skin biopsies showed that the second resting phase of the hair cycle started at about 45 days of age. Consequently the application of test substances was started when animals were 6.5 to 8 weeks old. Males then weighed about 20 g, females about 15 g
- Route of administration:
- oral: feed
- Vehicle:
- other: incorporated in food
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 300 days
- Frequency of treatment:
- 1/2 a day
- Post exposure period:
- 28 weeks
- Remarks:
- Doses / Concentrations:
15 mg/day
Basis:
nominal in diet - No. of animals per sex per dose:
- 30 in total
- Control animals:
- yes, concurrent no treatment
- other: same induction, no treatment
- Details on study design:
- Initiating was performed giving a solution of 4-nitroquinoline 1- oxide (NQO) trough stomach tube three times a week for two weeks. Each intubation was done in the morning and had been preceded by 17 hors of fasting. The initial dose was 0.1 mg, the following doses were 0.2 mg each.
- Observations and examinations performed and frequency:
- The animals were inspected and weighted once every two weeks
- Sacrifice and pathology:
- Surviving animals after 300 days were killed at 84 weeks. Authopsy was performed on all mice. The stomach, spleen, left kidney, liver, lungs and hearth were routinely examined histologically
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 8 death on 30 after 54 weeks
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 8 death on 30 after 54 weeks
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- See table below
- Relevance of carcinogenic effects / potential:
- No relevance of carcinogenic effect/potential
- Conclusions:
- No relevance of carcinogenic effect/potential
- Executive summary:
Two fatty acid methyl esters, methyl oleate and methyl 12-oxo-trans-10-octadecenoate, have been tested for carcinogenicty by oral and subcutaneous administration in ST/a mice of both sexes. A positive effect of methyl oleate could not be assessed, while the results pointed to a promoter effect of methyl oxo-octadecenoate. Given in the diet, this compound increased the incidence and number of forestomach papillomas within 83 weeks after initiation by 4-nitroguinoline 1-oxide.
Reference
| Initiator | Promoter | N° of mice | Survivors at 57 weeks | Survivors at 84 weeks | N° mice with lymphoma | N° mice with papilloma | N° of papillomas |
| None | None | 30 | 20 | 9 | 2 | 0 | 0 |
| NQO | None | 30 | 19 | 5 | 2 | 4 | 4 |
| NQO | Methyl oleate | 30 | 22 | 15 | 2 | 5 | 8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Remarks:
- read across on structural analogue
- Adequacy of study:
- weight of evidence
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is old and with some details missing.
- Qualifier:
- no guideline followed
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.32 (Carcinogenicity Test)
- Deviations:
- yes
- Remarks:
- Only one year dosing
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- Strain A
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animal were fed a commercial pellet stock diet
The applications started when the animals were 6.5-8 weeks old within a resting phase of their hair cycle - Route of administration:
- dermal
- Vehicle:
- acetone
- Details on exposure:
- 3 times per week applied by means of a syringe to the interscapular region of each animal
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 1 year
- Frequency of treatment:
- 3 times per week
- Post exposure period:
- no
- Remarks:
- Doses / Concentrations:
10 micrograms
Basis:
nominal conc. - No. of animals per sex per dose:
- 35 animals in total
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Initiation was accomplished by a single application of 50 micrograms dimethylbenzanthracene. A control group of animals was given the effectively dose of 250 micrograms.
Promotion was started 2 weeks after initiation. Croton oil was used as positive control promoter. Animals to which no promoter was applied served as negative control group. Further control groups were given the same tretments with respect to promoters but without previous initiation. The animals were inspected weekly.
Papillomas were counted when at least 1 mm in diameter and observed for 3 weeks in succession.
Dead mice were autopsied and tmors xamined histologically - Observations and examinations performed and frequency:
- Animals were inspected once a week
- Sacrifice and pathology:
- Dead mice were autopsied and tmors xamined histologically
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- at 12 months survivors are 82% while the control are 64%
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- at 12 months survivors are 82% while the control are 64%
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- See table below
- Relevance of carcinogenic effects / potential:
- No relevance of carcinogenic effect/potential
- Dose descriptor:
- NOAEC
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified. Effect type:carcinogenicity (migrated information)
- Conclusions:
- No relevance of carcinogenic effect/potential
- Executive summary:
Methyl 12 -oxo-trans-10 -octadecenoate and methyl hydroxyoctadecadienoate were tested for carginogenic and tumor promoting activity on mouse skin. Methyl oleate, which was inactive in the preliminary screening was also tested. No safe evidence of any proper carcinogenic effect of the fatty acid esters was found; some degree of tumor promoting activity could be further investigated
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Remarks:
- read across on structural analogue
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is old, not GLP, but well described and scientifically valid
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.32 (Carcinogenicity Test)
- Deviations:
- yes
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- Strain A
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female inbred ST/a mice, originating from the Fibiger Laboratory and bred in our laboratory, were housed in macrolone cages and fed a pellet stok diet (Rostock mixture, Copenhagen) with water ad libitum. Preliminary experiments using hair colouring and skin biopsies showed that the second resting phase of the hair cycle started at about 45 days of age. Consequently the application of test substances was started when animals were 6.5 to 8 weeks old. Males then weighed about 20 g, females about 15 g
- Route of administration:
- dermal
- Vehicle:
- acetone
- Details on exposure:
- 3 times per week applied by means of a syringe to the interscapular region of each animal
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 1 year
- Frequency of treatment:
- 3 times a week
- Post exposure period:
- 1 year
- Remarks:
- Doses / Concentrations:
0.01 mg
Basis:
nominal conc. - No. of animals per sex per dose:
- 35 in total
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Initiation was accomplished by a single application of 50 micrograms dimethylbenzanthracene.
Promotion was started 2 weeks after initiation. Croton oil was used as positive control promoter. Animals to which no promoter was applied served as negative control group. Further control groups were given the same tretments with respect to promoters but without previous initiation. The animals were inspected weekly.
Papillomas were counted when at least 1 mm in diameter and observed for 3 weeks in succession.
Dead mice were autopsied and tumors examined histologically - Positive control:
- Croton oil was used as positive control promoter
- Observations and examinations performed and frequency:
- Papillomas were counted when at least 1 mm in diameter and observed for 3 weeks in succession.
Dead mice were autopsied and tumors examined histologically
Autopsy was performed on all mice, and the interscapular skin, left kidney, spleen, liver, heart and lungs were routinely processed for histological study. Papillomas were confirmed histologically if not regressed before the death of the animal. - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 9 survivolrs females after 24 months
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 9 survivolrs females after 24 months
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Twelve of 13 cases of amyloidosis were seen in male mice and thy shoed a high fighting activity. The amylosis was then correlated with wounding and stress in submissive male mice
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- See table below
- Relevance of carcinogenic effects / potential:
- No relevance of carcinogenic effect/potential
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified. Effect type:carcinogenicity (migrated information)
- Conclusions:
- No relevance of carcinogenic effect/potential
- Executive summary:
Methyl 12 -oxo-trans-10 -octadecenoate and methyl hydroxyoctadecadienoate were tested for carginogenic and tumor promoting activity on mouse skin. Methyl oleate, which was inactive in the preliminary screening was also tested. No safe evidence of any proper carcinogenic effect of the fatty acid esters was found; some degree of tumor promoting activity could be further investigated
Referenceopen allclose all
| Initiator | Promoter | N° of mice | Survivolrs at 24 months | N° mice with lymphoma | Days to first skin tumor |
| None | None | 25 | 8 | 4 | 712 |
| None | Methyl oleate | 35 | 9 | 9 | 406 |
| DMBA | None | 20 | 4 | 2 | 667 |
| DMBA | Methyl oleate | 30 | 0 | 2 | 239 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
All studies are of poor quality and of questionable relevance.
1.1.1 Conclusion
No classification for carcinogenicity warranted under 67/548/EEC or Regulation 1272/2008.
Additional information
No relevance of carcinogenic effect/potential
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